MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP STB TB IN 5 17.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2154
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/23/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Clinical notification received for revision of left total knee to address instability.Date of implantation: (b)(6) 2007, date of revision: (b)(6) 2009, (left knee).Treatment: revision of tibial insert.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: product code 962154, work order (b)(4), was manufactured on 23 may 2007.(b)(4) parts were manufactured per specification and all raw materials met specification.No non-conformances or deviations were identified against this lot.

• Brand Name: PFC SIGMARP STB TB IN 5 17.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10862680
• Report Number: 1818910-2020-24939
• Device Sequence Number: 3803012
• Product Code: NJL
• UDI-Device Identifier: 10603295241430
• UDI-Public: 10603295241430
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: -
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 96-2154
• Device Catalogue Number: 962154
• Device Lot Number: 2388840
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT CEM KEEL TIB TRAY SZ4.; PFC*SIGMA C/S NPOR FEM LT SZ 5.; PFC*SIGMA/OV/DOME PAT 3PEG,41.; SMARTSET HV BONE CEMENT 40G.; SMARTSET HV BONE CEMENT 40G.; SMARTSET HV BONE CEMENT 40G.; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA C/S NPOR FEM LT SZ 5; PFC*SIGMA/OV/DOME PAT 3PEG,41; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 88